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Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers

NCT02725112 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-01-20

No results posted yet for this study

Summary

This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6 sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence) healthy male and female subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive will be enrolled. Subjects who discontinue from the study may be replaced at the Sponsor's discretion. Screening activities will be completed within approximately 28 days prior to Day 1 of Period 1. Subjects will be randomized to 1 of the 6 treatment sequences as described in Table 1 below. Each treatment sequence will consist of 6 periods with subjects receiving single doses of pregabalin ER 330 mg target release rate tablet, pregabalin ER 330 mg slow release rate tablet, pregabalin ER 330 mg fast release rate tablet, pregabalin IR 300 mg capsule, pregabalin ER 82.5 mg target release rate tablet, and pregabalin ER 330 mg aberrant fast release rate tablet formulations. All study treatments will be administered following a 600- 750 calorie, 30% fat evening meal.

Conditions

  • Healthy

Interventions

DRUG

Pregabalin ER

A: Pregabalin ER tablet formulation, Target release rate, 1 x 330 mg, Oral.

DRUG

Pregabalin ER

B: Pregabalin ER tablet formulation, Slow release rate, 1 x 330 mg, Oral.

DRUG

Pregabalin ER

C: Pregabalin ER tablet formulation, Fast release rate, 1 x 330 mg, Oral.

DRUG

Pregabalin ER

D: Pregabalin IR capsule formulation, 1 x 300 mg, Oral.

DRUG

Pregabalin ER

E: Pregabalin ER tablet formulation, Target release rate, 1 x 82.5 mg, Oral.

DRUG

Pregabalin ER

F: Pregabalin ER tablet formulation, Aberrant fast release rate, 1 x 330 mg, Oral.

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-12
Primary Completion
2016-05-22
Completion
2016-06-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02725112 on ClinicalTrials.gov